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Lidocaine for Pessary Check Pain Reduction

Sponsor
University of South Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05493735
Collaborator
(none)
96
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to estimate the effect of lidocaine jelly on patient pain at the time of office pessary removal.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine Hcl 2% Jelly
  • Drug: Placebo Jelly
 Phase 3

Detailed Description

The purpose of the study is to investigate the effects of lidocaine jelly on patient pain at the time of office pessary removal and reinsertion. All patients presenting to the University of South Florida Urogynecology clinic for a pessary maintenance appointment or "pessary check" will be screened as potential study participants. After being informed of risks and benefits of participation, informed consent will be obtained. Patients will be randomized into two groups: the control group or experimental group. The patient will complete a brief questionnaire and pain assessment using a Visual Analog Scale (VAS).

Both patients and investigators will be blinded. Therefore, the study research study nurse will apply the jelly (lidocaine vs lubricating). The participant will have an equal chance of being in the control arm or experimental arm. After 5 minutes, the investigator will assess the patient's genital hiatus with valsalva and proceed with pessary removal per the investigator's routine. The patient will complete another VAS to indicate pain level after pessary removal. The investigator will perform a speculum exam per routine and then reinsert the pessary. The patient will complete a final VAS to indicate level of pain after pessary reinsertion along with a brief final questionnaire.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Lidocaine for Pessary Removal and Reinsertion Pain Reduction
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Lubricating jelly (placebo) will be placed in the vagina to the level of the pessary, five minutes prior to pessary removal.

Drug: Placebo Jelly
Participants in the control arm will undergo pessary removal and reinsertion after the application of lubricating jelly.
Other Names:
  • Lubricating Gel
  • Vaginal Lubricant

    		•
    Experimental: Experimental

    Lidocaine jelly will be placed in the vagina to the level of the pessary, five minutes prior to the pessary removal.

    Drug: Lidocaine Hcl 2% Jelly
    Participants in the experimental arm will undergo pessary removal and reinsertion after the application of lidocaine topical gel.
    Other Names:
  • Lidocaine Jelly

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in patient's pain using the visual analog scale (VAS) after pessary removal [0 and 5 minutes]

      Self-reported pain level at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)

    Secondary Outcome Measures

    1. Change in patient's pain using the visual analog scale (VAS) after pessary reinsertion [0 and 10 minutes]

      Self-reported pain level at time of pessary reinsertion controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)

    2. Genital Hiatus with Valsalva [0 minutes]

      Genital hiatus measurement in centimeters prior to removal of the pessary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Women aged 18 years or older

    • Presenting for routine pessary management for prolapse, stress urinary incontinence, or both with a pessary in place

    • able to provide written informed consent

    • able to complete the visual analog scale

    Exclusion Criteria:

    • Women less than 18 years of age.

    • Patients who speak neither English nor Spanish

    • Pregnancy

    • Medical contraindication to lidocaine

    • Patients who remove and reinsert their pessary at home

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of South Florida

    Investigators

    • Principal Investigator: Araba A Jackson, MD, University of South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT05493735
    Other Study ID Numbers:
    • Pro004522
    First Posted:
    Aug 9, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of South Florida
    Pessary
    Lidocaine
    Pain Reduction
    Pessary Check
    Pessary Removal
    Pessary Reinsertion
    Lubricating Jelly
    Additional relevant MeSH terms:
    Urinary Incontinence
    Urinary Incontinence, Stress
    Prolapse
    Pelvic Organ Prolapse
    Lidocaine

    Study Results

    No Results Posted as of Aug 17, 2022